NCT03032705

Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities. In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.

Detailed description

This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique. The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories: Esthetic Properties * Surface luster * Staining - surface * Staining - margin * Color match and translucency * Esthetic anatomical form Functional Properties * Fracture of material and retention * Marginal adaptation * Approximate anatomical form - contact point * Radio-graphic examination (when applicable) * Patient's view Biological Properties * Postoperative (hyper-)sensitivity and tooth vitality * Recurrence of caries, erosion, abfraction * Tooth integrity (enamel cracks, tooth fractures) * Adjacent mucosa The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	SonicFill™ 2	The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
DEVICE	Filtek™ Supreme	The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.

Timeline

• Start date: 2017-06-19
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2017-01-26
• Last updated: 2021-12-13
• Results posted: 2021-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study